Csv engineer Job at Algoteque (Boxmeer)

Life sciences Computer System Validation Engineer

As a quality and compliance expert, you will be responsible for ensuring that Gx...

Location

Belgium , Machelen

Salary:

Not provided

Sopra Steria

Expiration Date

Until further notice

Requirements

Proven CSV experience in multiple projects or strong interest in CSV
Strong affinity with IT
Analytical and pragmatic thinking skills
Strong prioritization and planning skills
Strong sense of responsibility and accountability
A positive, solution-driven mindset
Excellent written and oral communication skills in Dutch and English
Basic knowledge of IT infrastructure qualification
A team player, but also able to work independently
Familiar with applicable regulatory standards and guidelines (21CFR Part 11, EU Annex 11, GDPR, GAMP5, ISO 9001,...) and concepts such as QMS, CAPAs, Data Integrity,...

Job Responsibility

Ensure that GxP systems and processes adhere to the applicable regulatory requirements throughout the entire system lifecycle
Stay up to date about evolving regulations from authorities such as the EMA and FDA and industry standards like GAMP and ISO
Provide Quality & Compliance support during audits and inspections
Join a Sopra Steria validation service team
Ensure the quality and regulatory compliance of GxP systems throughout their entire life cycle and across all GxP areas (GLP, GCP, GMP, GDP, GPvP)

What we offer

Mobility options (including a company car)
Insurance coverage
Meal vouchers
Eco-cheques
Continuous learning opportunities through the Sopra Steria Academy
Opportunity to connect with fellow Sopra Steria colleagues at various team events

Life Sciences Computer System Validation Engineer

As a V.I.E. in the Life Sciences division, you will support the validation and c...

Location

Belgium

Salary:

Not provided

Sopra Steria

Expiration Date

Until further notice

Requirements

Strong interest in CSV
strong affinity with IT
analytical and pragmatic thinking skills
strong prioritization and planning skills
strong sense of responsibility and accountability
a positive, solution-driven mindset
excellent written and oral communication skills in English
basic knowledge of IT infrastructure qualification
a team player, but also able to work independently
familiar with applicable regulatory standards and guidelines (21CFR Part 11, EU Annex 11, GDPR, GAMP5, ISO 9001,...) and concepts such as QMS, CAPAs, Data Integrity,...

Job Responsibility

Support the validation and compliance of computerized systems used in regulated environments
ensure GxP systems meet regulatory standards throughout their lifecycle
contribute to audits
stay informed on evolving regulations (EMA, FDA, GAMP, ISO)
work closely with Sopra Steria’s validation service teams.

What we offer

An international experience: be part of an innovative company with global reach
a stimulating environment: work on ambitious projects and collaborate with industry experts
a dynamic company culture: join a human-sized team within a large group
career growth opportunities: potential for long-term career development in Canada or within the Sopra Steria Group.

Fulltime

Senior Validation Engineer

Master Compliance, Inc. in Irving, TX is seeking Senior Validation Engineer(s) t...

Location

United States , Irving

Salary:

108722.00 USD / Year

Master Compliance Inc

Expiration Date

Until further notice

Requirements

Master’s degree in Electrical/Electronic Engineering, Energy Management, or any related field of study and 1-year of experience in the job offered or in any related position(s) in which the required experience was gained
Engineering principles and concepts relevant to validation processes
Industry regulations and standards (FDA, ISO, or GMP)
Validation documentation, including protocols, reports, and test plans
Validation testing, including IQ/OQ/PQ (Installation Qualification/Operational Qualification/ Performance Qualification)
Analyze and interpret validation data, ensuring compliance with established criteria and specifications
Risk assessments related to validation processes and develop mitigation strategies
Quality management principles and validation activities to meet quality standards
Validation equipment and instrumentation
Develop and execute validation protocols for equipment, processes, or systems

Job Responsibility

Lead the IT Validation activities for cloud based computerized systems and applications
Manage end to end validation documentation validation plan, training plan, issues log, design review, IQ protocol/report, OQ protocol/ report, PQ protocol/ report, test cases, test incidents, trace matrix, change controls and validation report
Author and manage the documents required for the development and validation of client’s cloud-based computerized systems, applications, and software
Follow the client validation procedures and requirements in validating new or modified processes and/or systems
Represent validation team in Business workshops, requirement gathering sessions and develop user requirements, system requirements including system flow diagram specifications, configuration, and design specifications
Manage and Plan for all validation testing activities (OQ, PQ and pre-validation UAT protocols) and lead deviation management activities
Develop test strategy and plan in execution of operational and performance protocols
Implement risk based approach and ensure validation tasks are aligned with healthcare regulations and clients SOPS
Lead change control management , Deviation Management ,APA’s investigation
Gather CSV metrics for reporting purposes

Fulltime

Computer Systems Validation Engineer

Understand and analyze requirements, define tasks and execute them. Involve in p...

Location

United States , Piscataway, NJ and various unanticipated locations throughout the U.S.

Salary:

Not provided

National Computer Systems

Expiration Date

Until further notice

Requirements

CAPA
CGXP
GAMP
HP ALM
CSV
21 CFR
Audit Trial
Agile
GAP Analysis
Service Now

Job Responsibility

Understand and analyze requirements, define tasks and execute them
Involve in preparing documentation for all aspects of the computer system validation life cycle
Design, deliver, support and maintain GxP computerized systems and security of the associated data
Create and review validation plans, user requirement specifications, functional/design specifications, system integration and user acceptance test design and traceability matrix
Validate models for risk management and compliance
Coordinate with offshore team in an onsite-offshore model

What we offer

Referring employee will be eligible to receive an award of $1,000.00 for the successful referral

Life sciences quality and compliance engineer

As a Quality & Compliance Engineer, you will ensure that products, processes, sy...

Location

Belgium , Machelen

Salary:

Not provided

Sopra Steria

Expiration Date

Until further notice

Requirements

Graduate with a Master's degree in a scientific direction (Industrial Ir, Bio Ir, Chemie, Biotechnology, Pharmacy,...) or equivalent by experience
Experienced in working in a regulated environment, with developed document writing skills
You demonstrate the consultancy mindset by being pro-active, taking ownership and showing commitment
Problem solving mindset and eager to learn and evolve
You have a strong sense of responsibility and an eye for quality
You will contribute to projects for top companies, both nationally and internationally
Teamplayer with the ability to go in full focus-mode when independent work is required

Job Responsibility

Ensure that products, processes, systems and services in the world of Life Sciences meet regional and global quality regulations and standards
Active in various areas such as computer system validation (CSV), MES, lab qualification, Quality Assurance, Engineering

What we offer

Mobility options (including a company car)
Insurance coverage
Meal vouchers
Eco-cheques
Continuous learning opportunities through the Sopra Steria Academy
Opportunity to connect with fellow Sopra Steria colleagues at various team events

Life sciences Qualification engineer

As a qualification engineer you will work on projects in the life science indust...

Location

Belgium , Machelen

Salary:

Not provided

Sopra Steria

Expiration Date

Until further notice

Requirements

You hold a master's or bachelor degree in a scientific direction (engineering, chemistry, biochemistry, biotechnology, biomedical sciences, pharmaceutical sciences, ...) or equivalent by experience
You are experienced in working in a regulated environment, with developed document writing skills and an eye for quality
You demonstrate the consultancy mindset by being pro-active, taking ownership and showing commitment
You have a problem-solving mindset and a strong sense of responsibility
You want to learn and evolve
You can work independently as well as in a team
You speak Dutch and English fluently

Job Responsibility

Ensure that products, processes, systems, services, and documentation meet regional and global quality regulations and standards
Activities take place in a laboratory or production environment, or can relate to business technologies
Active in various areas such as computer system validation (CSV), lab instrument qualification, method validation, cleaning validation, engineering, quality assurance, business analysis, project management

What we offer

A variety of perks, such as mobility options (including a company car), insurance coverage, meal vouchers, eco-cheques, and more
Continuous learning opportunities through the Sopra Steria Academy to support your career development
The opportunity to connect with fellow Sopra Steria colleagues at various team events

Fulltime

Python Developer

This AI-driven initiative focuses on improving the client's smart video ecosyste...

Location

Salary:

Not provided

Coherent Solutions

Expiration Date

Until further notice

Requirements

5+ years of strong Python backend development experience
Strong engineering mindset with focus on correctness, maintainability, and long-term extensibility
Experience building production-grade RESTful APIs and microservices
Ability to write clean, readable, maintainable, and well-structured code
Strong understanding of conditional logic, control flow, and deterministic execution in backend systems
Ability to understand decision-table-based logic and implement similar behavior based on existing examples or specifications

Job Responsibility

Design and implement rules/decision engine in Python
Build logic to ingest rule definitions from CSV or similar tabular formats and interpret “given” conditions and corresponding “action” outputs to execute rules deterministically at runtime
Implement decision-table semantics, including ordered rule evaluation, conditional branching and correct handling of overlapping or missing conditions
Ensure rules can be updated, validated, and tested safely
Maintain high performance and reliability for real-time rule evaluation
Collaborate with product, backend, and AI/ML teams to align rule logic with business needs
Write robust, testable, and maintainable Python code

What we offer

Technical and non-technical training for professional and personal growth
Internal conferences and meetups to learn from industry experts
Support and mentorship from an experienced employee to help you professional grow and development
Internal startup incubator
Health insurance
English courses
Sports activities to promote a healthy lifestyle
Flexible work options, including remote and hybrid opportunities
Referral program for bringing in new talent
Work anniversary program and additional vacation days

Business Development Manager Pharma & Biotech

Are you a sales person with passion, do you inspire customers for our innovative...

Location

Belgium , Antwerp

Salary:

Not provided

ATS Automation Tooling Systems Inc.

Expiration Date

Until further notice

Requirements

Min. Bachelor’s degree in engineering, sales, marketing or related field
Experience and (basic) understanding of life sciences manufacturing practices (Automation, GAMP, CSV) would be an asset
Working experience of at least 5 years in Sales Operations or as a project engineer, lead engineer or specialist and ready for the next step
Basic understanding of Automation and/or MES PA portfolio of solutions and services
Ability to develop effective customer relationship to generate sales opportunities
Experience in customer relation management
Demonstrate a passion and genuine desire to draw insights that will lead to the development of effective sales strategies
Good communication skills with an ability to tailor messages for any audience on technical and business side
French and Dutch are required

Job Responsibility

Defining the individual approach to specific customers in order to create strong and lasting relationships and to achieve designated sales targets
Creates opportunities for the business by gathering information and keeping the business up to date
Planning and executing effective sales activities in line with the business strategy that are focused on customer satisfaction and revenue generation
Analyse the business’s sales operations information and leverages important information in the development of sales operations approaches
Develops an in-depth knowledge of the business’s core solutions through the completion of training programs and the conversion in sales activities
Works closely with operation departments, the marketing department, digital solution architects and the product development department to optimize the value selling towards the customer
Work closely with your global sales colleagues to create a growth strategy for your customers

What we offer

Exclusive compensation package: We offer a competitive salary, complemented by additional benefits
Flexible working hours: We provide flexible working hours and the option to work remotely, tailored to your professional lifestyle
Sustainable mobility solutions: You will receive a fully electric company car, including a charging card and the option for a home charging station. Additionally, charging facilities are available at our offices
Continuous professional development: Broaden your horizons with ongoing personal and professional growth opportunities, both horizontally and vertically
Fun team environment: We regularly organize team events such as Christmas parties, social quarterly drinks, sports tournaments, and more

Fulltime

Csv engineer

Algoteque

Location:
Netherlands , Boxmeer

Category:
IT - Software Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
January 24, 2026

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Life sciences Computer System Validation Engineer